References
- Gibson M. Pharmaceutical preformulation and formulation: a pratical guide from candidate drug selection to commercial dosage form. Englewood (CO): Interpharm Press; 2001
- Sathish HA, Kumar PR, Prakash V. Mechanism of solvent induced thermal stabilization of papain. Int J Biol Macromol 2007;41:383–90
- Polaina J, MacCabe AP. Industrial enzymes structure, function and applications. Netherlands: Springer; 2007
- Sangeetha K, Abraham ET. Chemical modification of papain for use in alkaline medium. J Mol Catal B: Enzym 2006;38:171–7
- Sharma M, Sharma V, Panda AK, Majumdar DK. Enteric microsphere formulations of papain for oral delivery. Yakugaku Zasshi 2011;131:697–709
- Sharma M, Sharma V, Panda AK, Majumdar DK. Development of enteric submicron particle formulation of papain for oral delivery. Int J Nanomedicine 2011;6:2097–111
- Müller C, Leithner K, Hauptstein S, et al. Preparation and characterization of mucus-penetrating papain/poly(acrylic acid) nanoparticles for oral drug delivery applications. J Nanopart Res 2013;15:1353 (1--13)
- Kristó K, Bajdik J, Kleinebudde P, Pintye-Hódi K. Effect of lubricant on spreading of coating liquid on surface of tablets containing pancreatin. Pharm Dev Technol 2010;15:354–9
- Van der Merwe SM, Verhoef JC, Kotzé AF, Junginger HE. N-trimethyl chitosan chloride as absorption enhancer in oral peptide drug delivery. Development and characterization of minitablet and granule formulations. Eur J Pharm Biopharm 2004;57:85–91
- Trivedi NR, Rajan MG, Johnson JR, Shukla AT. Pharmaceutical approaches to preparing pelletized dosage forms using the extrusion-spheronization process. Crit Rev Ther Drug Carrier Syst 2007;24:1–40
- Pisal DS, Kosloski MP, Balu-Iyer SV. Delivery of therapeutic proteins. J Pharm Sci 2010;99:2557–75
- Aulton ME. Pharmaceutics – the science of dosage form design. New York: Churchill Livingstone; 2005
- Sousa JJ, Sousa A, Podczeck F, Newton JM. Factors influencing the physical characteristics of pellets obtained by extrusion-spheronization. Int J Pharm 2002;232:91–106
- Vervaet C, Baert L, Remon JP. Extrusion-spheronization: a literature review. Int J Pharm 1994;4:108–207
- Erlanger BF, Kokowsky N, Cohen W. The preparation and properties of two new chromogenic substrates of trypsin. Arch Biochem Biophys 1961;95:271–8
- Stanisz B, Regulska K, Kania J, Garbacki P. Effect of pharmaceutical excipients on the stability of angiotensin-converting enzyme inhibitors in their solid dosage formulations. Drug Dev Ind Pharm 2013;39:51–61
- Fekete R, Zelkó R, Marton S, Rácz I. Effect of the formulation parameters on the characteristics of pellets. Drug Dev Ind Pharm 1998;24:1073–6
- Agrawal AM, Howard MA, Neau SH. Extruded and spheronized beads containing no microcrystalline cellulose: influence of formulation and process variables. Pharm Dev Technol 2004;9:197–217
- Bölcskei E, Regdon G, Sovány T, et al. Preparing of pellets by extrusion/spheronization using different types of equipment and process conditions. 2013. [Epub ahead of print]. doi:10.3109/03639045.2013.783588
- Alvarez L, Concheiro A, Gómez-Amoza JL, et al. Effect of microcrystalline cellulose grade and process variables on pellets prepared by extrusion–spheronization. Drug Dev Ind Pharm 2002;28:451–6
- Umprayn K, Chitropas P, Amarekajorn S. Influence of process variables on physical properties of the pellets using extruder and spheronizer. Drug Dev Ind Pharm 1999;25:46–61
- Morales JO, Joks GM, Lamprecht A, et al. A design of experiments to optimize a new manufacturing process for high activity protein-containing submicron particles. Drug Dev Ind Pharm 2013;39:1793–801
- Häring A, Vetchý D, Janovská H, et al. Differences in characteristics of pellets prepared by different pelletization methods. Drug Dev Ind Pharm 2008;34:289–96
- Chang BS, Hershenson S. Practical approaches to protein formulation development. Pharmaceut biotechnol 2002;13:1–25
- Jain SP, Singh PP, Amin PD. Alternative extrusion–spheronization aids. Drug Dev Ind Pharm 2010;36:1364–76
- Issa GM, Pessole L, Takahashi AK, et al. Physicochemical and dissolution profile characterization of pellets containing different binders obtained by the extrusion-spheronization process. Braz J Pharm Sci 2012;48:379–88
- Ohrem HL, Schornick E, Kalivoda A, Ognibene R. Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms? Pharm Dev Technol 2014;19:257–62
- Goyanes A, Souto C, Martínez-Pacheco R. Control of drug release by incorporation of sorbitol or mannitol in microcrystalline-cellulose-based pellets prepared by extrusion-spheronization. Pharm Dev Technol 2010;15:626–35
- Rowe RC, Sheskey PJ, Walter G, Fenton ME. Handbook of pharmaceutical excipients. 7th ed. London: Pharmaceutical Press; 2012
- Arakawa T, Prestrelski S, Kinney W, Carpenter, JF. Factors affecting short-term and long-term stabilities of proteins. Adv Drug Delivery Rev 2001;46:307--26
- Arakawa T, Timasheff SN. Stabilization of protein structure by sugars. Biochemistry 1982;21:6536–44
- Andreo-Filho N, Pessole L, Issa MG, et al. Gastro-resistant pellets of didanosine obtained by extrusion and spheronization: assessing the production process. Lat Am J Pham 2009;28:32–40
- Rahman Md A, Ahuja A, Baboota S, et al. Recent advances in pelletization technique for oral drug delivery: a review. Curr Drug Delivery 2009;6:122–9
- Santos HMM, Veiga FJB, Pina MET, Sousa JJMS. Obtenção de pellets por extrusão e esferonização farmacêutica. Parte II. Avaliação das características física de pellets. Braz J Pham Sci 2006;42:309–18
- Wang W. Lyophilization and development of solid protein Pharmaceuticals. Int J Pharm 2000;203:1–60
- Hellerman L, Perkins ME. Activation of enzymes II: papain activity as influenced by oxidation–reduction and by the action of metal compounds. J Biol Chem 1934;107:241–55
- Kamphuis IG, Kalk KH, Swarte MB, Drenth J. Structure of papain refined at 1.65 A resolution. J Mol Biol 1984;179:233–56
- Homaei AA, Sajedi RH, Sariri R, et al. Cysteine enhances activity and stability of immobilized papain. Amino acids 2010;38:937–42
- Santos HMM, Veiga FJB, Pina MET, Sousa JJMS. Obtenção de pellets por extrusão e esferonização farmacêutica. Parte I. Avaliação das variáveis tecnológicas e de formulação. Braz J Pham Sci 2004;40:455–70